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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002768 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission.
Condition | Intervention | Phase |
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Leukemia |
Biological: filgrastim Drug: busulfan Drug: cytarabine Drug: etoposide Drug: methotrexate Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION: A PHASE II STUDY |
Estimated Enrollment: | 48 |
Study Start Date: | June 1996 |
OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral blood stem cell transplantation to generate a 2-year disease-free survival rate in at least 30% of patients with acute myeloid leukemia (AML) in second complete remission. II. Determine whether the treatment-related mortality can be limited to less than 20% in patients treated with this regimen. III. Determine whether adequate numbers of PBSC can be collected in these patients. IV. Determine the engraftment kinetics of primed PBSC obtained from these patients.
OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours and etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells. Conditioning: Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when blood counts recover, patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Patients with documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater before and/or after PBSC transplantation for a total of 6 doses.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.
Ages Eligible for Study: | 15 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) in second complete remission (CR) for 30 days to less than 1 year before study entry Second CR defined by the following: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Normal bone marrow morphology with no excess blasts (greater than 5%) No myelodysplasia No extramedullary or CNS leukemia Initial diagnosis of de novo AML (M0-M7) No prior myelodysplasia No myeloproliferative disease No secondary AML Cytogenetics not required No cytogenetic evidence of persistent leukemia if cytogenetics performed
PATIENT CHARACTERISTICS: Age: 15 to 69 Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal No cirrhosis or chronic hepatitis Biopsy required if chronic liver disease suspected (history of alcohol abuse or possible hepatitis) Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow/stem cell transplantation Chemotherapy: Prior non-ablative chemotherapy at initial diagnosis, during initial remission, or as reinduction therapy (to produce current second remission) allowed At least 4 weeks since hospital discharge after reinduction therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior post-remission therapy for second remission
United States, California | |
UCSF Cancer Center and Cancer Research Institute | |
San Francisco, California, United States, 94115-0128 | |
United States, Maryland | |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, New Jersey | |
St. Joseph's Hospital and Medical Center | |
Paterson, New Jersey, United States, 07503 |
Study Chair: | Charles A. Linker, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000064734, CLB-9620 |
Study First Received: | November 1, 1999 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00002768 History of Changes |
Health Authority: | United States: Federal Government |
adult acute myeloid leukemia in remission adult acute erythroid leukemia (M6) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute promyelocytic leukemia (M3) |
adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute megakaryoblastic leukemia (M7) adult acute monocytic leukemia (M5b) adult acute minimally differentiated myeloid leukemia (M0) |
Leukemia, Monocytic, Acute Antimetabolites Anti-Infective Agents Immunologic Factors Acute Myelomonocytic Leukemia Folate Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Etoposide phosphate Vitamin B9 Leukemia Acute Erythroblastic Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Promyelocytic, Acute |
Methotrexate Etoposide Cytarabine Leukemia, Myeloid Folinic Acid Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Leukemia, Myelomonocytic, Acute Folic Acid Leukemia, Erythroblastic, Acute Busulfan Antirheumatic Agents Acute Promyelocytic Leukemia Di Guglielmo's Syndrome |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Leukemia, Myeloid, Acute Leukemia Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Cytarabine Neoplasms by Histologic Type Enzyme Inhibitors Leukemia, Myeloid Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Antirheumatic Agents |